Novartis awarded Prix Galien in France for innovative cancer therapy, Glivec®
First time award given two years in a row to same pharmaceutical company in one country; 12th Prix Galien overall for Novartis
Basel, 12 March 2002 – Novartis has been awarded the prestigious Prix Galien in France for the second year in a row, marking the first time that the same pharmaceutical company has won this distinction for two years in succession. This is the 12th time Novartis has been awarded the Prix Galien award for innovative therapies. The winning compound this year is Glivec® (imatinib)*, a treatment for patients with chronic myeloid leukemia (CML). Glivec, a signal transduction inhibitor, is one of the first cancer drugs to be developed using rational drug design, based on an understanding of how some cancer cells work.
"Winning twelve Prix Galien awards, and winning twice in a row in France, is a major accomplishment for Novartis," said Thomas Ebeling, CEO of Novartis Pharma. "It is especially rewarding to win the award for Glivec. This is a drug that the entire company worked very hard to bring to market and it offers CML patients real hope against their cancer."
About Glivec Glivec targets the activity of a type of enzyme, called tyrosine kinases, which play an important role within certain cancer cells. It works by inhibiting the the abnormality that characterizes CML in most patients. Additionally, the activity of one of the tyrosine kinases that Glivec has been shown to inhibit, known as c-kit, is thought to drive the growth and division of most GISTs.
Glivec was approved in the EU on 7 November 2001 for its initial treatment of chronic myeloid leukemia (CML) in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. To date, Novartis has received marketing clearance for Glivec for the CML indication in the European Union and more than 60 countries. The effectiveness of Glivec is based on overall hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival. In the treatment of CML, it is designated as an Orphan Drug in the United States, European Union and Japan. Novartis received a positive opinion for Glivec for the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST) from the Committee for Proprietary Medicinal Products (CPMP) in the EU on 22 February 2002. Glivec was also granted Orphan Drug designation by the European Union (EU) and the US for GIST.
About the Prix Galien The Prix Galien recognizes innovative therapeutic drugs that have made a substantial improvement in therapy. The prize is sponsored by medical media from different countries including Germany, France, Canada, and, since 2001, the United States. An independent jury consisting of top researchers and opinion leaders decides the winner. Since 1970, Novartis has received 12 Prix Galien in six countries for the innovative therapies Rimactan®, Parlodel®, Sandimmune®, Sandostatin®, Simulect®, Visudyne® (for which France won the award last year) and now Glivec®.
The foregoing release contains forward-looking statements that can be identified by terminology such as "offers CML patients real hope," or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Glivec to be materially different from any future results, performance or achievements expressed or implied by such statements. In particular, management's ability to ensure satisfaction of the FDA's further requirements is not guaranteed and management's expectations regarding further commercialization of Glivec could be affected by, among other things, additional analysis of data; new data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the Company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; and other risks and factors referred to in the Company's current Form 20-F on file with the Securities and Exchange Commission of the United States. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected.
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